Efficacy and safety of monoclonal antibodies against respiratory syncytial virus disease in premature infants: a systematic review and network meta-analysis

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Objective: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children, which may progress to bronchiolitis, pneumonia, and other severe respiratory complications. This study aimed to evaluate the efficacy and safety of monoclonal antibodies (mAbs) against the RSV disease in premature infants. Methods: A comprehensive literature search was conducted across the PubMed, Cochrane Library, and Embase databases from inception through December 2025. Statistical analyses were performed using STATA software (version 15.0). Effect estimates were expressed as relative risk (RR) with corresponding 95% confidence intervals, and treatment rankings were evaluated using the surface under the cumulative ranking curve (SUCRA) probability. Results: This Network Meta-analysis (NMA) included 7 randomized controlled trials involving 4 drugs and 11319 infants. Compared with the placebo, nirsevimab, motavizumab, and palivizumab have shown beneficial effects at reducing RSV-related hospitalization rates (RR, nirsevimab: 0.20, 95% CI: 0.09-0.45; motavizumab: 0.32 95% CI: 0.19-0.53; palivizumab: 0.43; 95% CI: 0.30-0.61) and Intensive Care Unit (ICU) admissions due to RSV infections (nirsevimab: 0.09, 95% CI: 0.01-0.87; motavizumab: 0.23, 95% CI: 0.08-0.65; palivizumab: 0.43, 95% CI: 0.21-0.90) in preterm infants. Nirsevimab was most likely to exert the best therapeutic effects, with the highest (SUCRA) values of 94.4% for RSV-related hospitalization rates and 89.1% for ICU admissions. No significant differences were found in mechanical ventilation use, deaths related to RSV Infections and drug-related adverse events. Conclusion: Nirsevimab, motavizumab, and palivizumab all reduced RSV-related hospitalizations and ICU admissions in preterm infants, with nirsevimab showing the greatest effect. However, further studies are needed to confirm these findings. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024583222, identifier CRD42024583222.